{"schema_version":"1.0","type":"article","title":"胃癌CLDN18.2 ADC對決：武田數據贏、AZ先上美國","url":"https://drugnews.com.tw/articles/2026-10-28-gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race.html","markdown_url":"https://drugnews.com.tw/articles/2026-10-28-gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race.md","lang":"zh-Hant","date":"2026-10-28","publish_at":"2026-10-28T08:00:00+08:00","updated_at":"2026-10-28","category":"醫學大會","topic":"醫學大會","tags":["胃癌","CLDN18.2","ADC","武田 Takeda","AstraZeneca"],"summary":"末線胃癌多活 3.3 個月，武田的 CLDN18.2 ADC 在 ESMO 交出漂亮成績單。但試驗只在中國和日本做，門檻又劃在 75%，美國第一支同類藥會是 AstraZeneca 的。","key_points":["AstraZeneca 的 sonesitatug vedotin 會比武田與信達的 arcotatug tavatecan 先拿到美國 FDA 核准，因為武田 2026 年 10 月 23 日在 ESMO 發表的 G-HOPE-001 三期只在中國與日本收案，要另做全球三期才能送美國。","G-HOPE-001 收治 464 位用過 2 到 4 線治療的 CLDN18.2 陽性胃癌病人，arcotatug tavatecan 組中位整體存活 10.2 個月、化療組 6.9 個月（HR 0.57），腫瘤縮小比例 37.4% 對 7.7%。","AstraZeneca 的 CLARITY-Gastric01 在 19 國收案、CLDN18.2 門檻只要 25% 癌細胞（約六成胃癌病人符合），武田與 Vyloy 用 75% 門檻；台灣健保自 2026 年 4 月 1 日起只給付一線的 Vyloy。"],"facts":[{"claim":"G-HOPE-001 三期收案人數（中國與日本）","value":464,"unit":"人","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"arcotatug tavatecan 組中位整體存活（G-HOPE-001 IA2）","value":10.2,"unit":"個月","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"G-HOPE-001 化療對照組中位整體存活","value":6.9,"unit":"個月","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"G-HOPE-001 整體存活風險比","value":0.57,"unit":"HR","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"G-HOPE-001 中位無惡化存活：藥物組對化療組","value":"7.1 vs 3.1","unit":"個月","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"G-HOPE-001 確認腫瘤縮小比例：藥物組對化療組","value":"37.4% vs 7.7%","unit":"%","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"G-HOPE-001 3 級以上治療相關不良事件：藥物組對化療組","value":"47.4% vs 55.9%","unit":"%","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"G-HOPE-001 3 級以上貧血：藥物組對化療組","value":"20.4% vs 13.1%","unit":"%","as_of":"2026-10-23","source":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"claim":"武田 2025 年 10 月付給信達的首付款（含 1 億美元入股）","value":12,"unit":"億美元","as_of":"2025-10-22","source":"https://www.biospace.com/press-releases/innovent-biologics-announces-global-strategic-partnership-with-takeda-to-bring-innovents-next-gen-io-backbone-therapy-and-adc-molecules-to-the-global-market"},{"claim":"武田與信達合作潛在總值","value":114,"unit":"億美元","as_of":"2025-10-22","source":"https://www.biospace.com/press-releases/innovent-biologics-announces-global-strategic-partnership-with-takeda-to-bring-innovents-next-gen-io-backbone-therapy-and-adc-molecules-to-the-global-market"},{"claim":"CLARITY-Gastric01 收案國家數與中心數","value":"19 國、175 個中心","unit":"","as_of":"2026-07-27","source":"https://www.astrazeneca.com/media-centre/press-releases/2026/sone-ve-improved-survival-in-gastric-cancers.html"},{"claim":"sonesitatug vedotin 的 CLDN18.2 門檻（任何染色強度的癌細胞比例）","value":25,"unit":"%","as_of":"2026-07-27","source":"https://www.astrazeneca.com/media-centre/press-releases/2026/sone-ve-improved-survival-in-gastric-cancers.html"},{"claim":"符合 25% 門檻的胃癌／胃食道交界癌比例（AstraZeneca 估計）","value":60,"unit":"%","as_of":"2026-07-27","source":"https://www.astrazeneca.com/media-centre/press-releases/2026/sone-ve-improved-survival-in-gastric-cancers.html"},{"claim":"GLOW 與 SPOTLIGHT 中 CLDN18.2 陽性（≥75% 中強染色）病人比例","value":38,"unit":"%","as_of":"2023-03-22","source":"https://newsroom.astellas.com/2023-03-22-Astellas-Announces-Positive-Findings-from-Phase-3-GLOW-Trial-of-Zolbetuximab-during-March-ASCO-Plenary-Series"},{"claim":"GLOW 三期中位整體存活：Vyloy 加化療對安慰劑加化療","value":"14.39 vs 12.16","unit":"個月","as_of":"2023-03-22","source":"https://newsroom.astellas.com/2023-03-22-Astellas-Announces-Positive-Findings-from-Phase-3-GLOW-Trial-of-Zolbetuximab-during-March-ASCO-Plenary-Series"},{"claim":"Vyloy 2025 財年（至 2026 年 3 月）全球營收","value":631,"unit":"億日圓","as_of":"2026-04-27","source":"https://www.astellas.com/content/dam/astellas-com/global/en/confidential-documents/financial-results/4q2025_sup_en.pdf"},{"claim":"Vyloy 2024 財年全球營收","value":122,"unit":"億日圓","as_of":"2026-04-27","source":"https://www.astellas.com/content/dam/astellas-com/global/en/confidential-documents/financial-results/4q2025_sup_en.pdf"},{"claim":"AstraZeneca 2023 年取得 CMG901（Sone-Ve）授權的首付款","value":6300,"unit":"萬美元","as_of":"2023-02-23","source":"https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-enters-license-agreement-with-kym-biosciences-for-cmg901-a-claudin-182-antibody-drug-conjugate.html"},{"claim":"台灣健保給付 Vyloy（zolbetuximab）生效日","value":"2026-04-01","unit":"日期","as_of":"2026-04-01","source":"https://www.nhi.gov.tw/ch/dl-97151-a6aec2bac5b0488a87cc56995538c5ca-1.pdf"},{"claim":"胃癌在台灣 2024 年十大癌症死因排名","value":8,"unit":"名","as_of":"2025-06-16","source":"https://www.mohw.gov.tw/cp-16-82775-1.html"},{"claim":"台灣每年新診斷胃癌人數（2022 年癌登）","value":"4,000 以上","unit":"人","as_of":"2025-02-19","source":"https://health.tvbs.com.tw/cancer/353026"}],"sections":["01｜胃癌細胞表面的一塊門牌","02｜武田的成績單：腫瘤縮小的人多了將近 5 倍","03｜同一把尺：誰能用、在哪裡試、什麼時候上市","04｜台灣胃癌病人：健保只給一線的 Vyloy","05｜兩條終點線","參考資料"],"references":[{"title":"Takeda Announces Arcotatug Tavatecan (TAK-921) Demonstrated Statistically Significant and Clinically Meaningful Improvements in Overall Survival and Progression-Free Survival in Phase 3 Advanced Gastric Cancer Study","source":"Takeda","date":"2026-10-23","url":"https://www.takeda.com/newsroom/newsreleases/2026/arcotatug-tavatecan-phase-3-study/"},{"title":"ESMO: Takeda's $1.2B bet on Innovent 'absolutely' pays off with details of ADC's phase 3 win","source":"Fierce Biotech","date":"2026-10-23","url":"https://www.fiercebiotech.com/biotech/esmo-takedas-12b-bet-innovent-absolutely-pays-adcs-phase-3-win"},{"title":"Innovent Biologics Announces Global Strategic Partnership with Takeda","source":"BioSpace（Innovent 新聞稿","date":"2025-10-22","url":"https://www.biospace.com/press-releases/innovent-biologics-announces-global-strategic-partnership-with-takeda-to-bring-innovents-next-gen-io-backbone-therapy-and-adc-molecules-to-the-global-market"},{"title":"Innovent, fresh from $1.2B deal, posts phase 3 win for Takeda-partnered ADC","source":"Fierce Biotech","date":"2026-06-04","url":"https://fiercebiotech.com/biotech/innovent-fresh-12b-deal-posts-phase-3-win-cldn182-adc"},{"title":"Sonesitatug vedotin demonstrated a statistically significant and highly clinically meaningful improvement in overall survival in 2nd and later-line CLDN18.2-positive advanced gastric/GEJ cancers","source":"AstraZeneca","date":"2026-07-27","url":"https://www.astrazeneca.com/media-centre/press-releases/2026/sone-ve-improved-survival-in-gastric-cancers.html"},{"title":"AstraZeneca to present overall survival data from four pivotal Phase III trials in Presidential Symposia at ESMO 2026","source":"AstraZeneca","date":"2026-10-19","url":"https://www.astrazeneca.com/media-centre/press-releases/2026/astrazeneca-present-survival-data-from-four-pivotal-phase-iii-trials-at-esmo-2026-featuring-sone-ve-imfinzi-tagrisso-orpathys.html"},{"title":"AstraZeneca enters license agreement with KYM Biosciences for CMG901, a Claudin 18.2 antibody drug conjugate","source":"AstraZeneca","date":"2023-02-23","url":"https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-enters-license-agreement-with-kym-biosciences-for-cmg901-a-claudin-182-antibody-drug-conjugate.html"},{"title":"Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab","source":"Astellas","date":"2023-03-22","url":"https://newsroom.astellas.com/2023-03-22-Astellas-Announces-Positive-Findings-from-Phase-3-GLOW-Trial-of-Zolbetuximab-during-March-ASCO-Plenary-Series"},{"title":"FY2025 Financial Results Supplementary Information（Sales of major products","source":"Astellas","date":"2026-04-27","url":"https://www.astellas.com/content/dam/astellas-com/global/en/confidential-documents/financial-results/4q2025_sup_en.pdf"},{"title":"藥品給付規定修訂對照表（9.133 zolbetuximab，115/4/1 生效","source":"衛福部中央健康保險署","date":"2026-04-01","url":"https://www.nhi.gov.tw/ch/dl-97151-a6aec2bac5b0488a87cc56995538c5ca-1.pdf"},{"title":"113 年死因統計結果分析","source":"衛生福利部","date":"2025-06-16","url":"https://www.mohw.gov.tw/cp-16-82775-1.html"},{"title":"年逾4千人罹胃癌！光做胃癌篩檢不夠","source":"TVBS 健康2.0","date":"2025-02-19","url":"https://health.tvbs.com.tw/cancer/353026"},{"title":"Sonesitatug Vedotin Improves Overall Survival in Second- and Later-Line CLDN18.2-Positive Gastric/GEJ Cancer","source":"OncLive","date":"2026-07-27","url":"https://www.onclive.com/view/sonesitatug-vedotin-improves-overall-survival-in-second--and-later-line-cldn18-2-positive-gastric-gej-cancer"}],"images":[{"alt":"圖1｜同一塊門牌，三種作法","url":"https://drugnews.com.tw/assets/articles/gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race/figure-01.png"},{"alt":"圖2｜末線胃癌，多活 3.3 個月","url":"https://drugnews.com.tw/assets/articles/gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race/figure-02.png"},{"alt":"圖3｜同一把尺量三支 CLDN18.2 藥","url":"https://drugnews.com.tw/assets/articles/gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race/figure-03.png"},{"alt":"圖4｜CLDN18.2 上市賽跑時間線","url":"https://drugnews.com.tw/assets/articles/gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race/figure-04.png"}],"cover_image":"https://drugnews.com.tw/assets/articles/gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race/cover.png","publisher":{"name":"Drugnews｜藥時事","url":"https://drugnews.com.tw/","profile":"https://drugnews.com.tw/brand-profile.json"},"citation":"Drugnews｜藥時事（2026-10-28）。胃癌CLDN18.2 ADC對決：武田數據贏、AZ先上美國。https://drugnews.com.tw/articles/2026-10-28-gastric-cancer-cldn18-2-adc-takeda-astrazeneca-race.html","disclaimer":"本文僅供產業研究與知識分享，不構成投資、醫療、募資或個股建議。","translations":{},"relationship":"independent_editorial","disclosure_url":"https://drugnews.com.tw/policy/"}